- Subjects with another active medical condition or organ disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. This includes, but is not limited to the following abnormalities: total bilirubin > 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) or clinically significant serum creatinine > 2 x ULN, international normalized ratio (INR) ≥ 2.0. Other excluded medical conditions including, but not limited to, history of heart attack, brain injury, low blood pressure and clinically significant irregular heartbeat.